Cleared Traditional

K251400 - T2 Alpha Humerus Nailing System

Also marketed or referenced as:
IMN Screws System T2 Nailing System

K251400 is an FDA 510(k) clearance for T2 Alpha Humerus Nailing System, manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K251400 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
106d
Days
Class 2
Risk

K251400 is an FDA 510(k) clearance for the T2 Alpha Humerus Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on August 20, 2025 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker GmbH devices

FDA 510(k) Submission Details - K251400

510(k) Number K251400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2025
Decision Date August 20, 2025
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K251400.
ARIX Femur Nail System
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K250197 · Citieffe S.R.L. · Oct 2025
DynaNail TTC Fusion System
K250628 · MedShape, Inc. · Sep 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · Stryker GmbH · Aug 2025
Succession™ AFN System
K250622 · Ortho Solutions UK , Ltd. · Aug 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · Paragon 28, Inc. · Jul 2025